Objective Many non-airway-trained personnel are uncomfortable managing altered airway anatomy (AAA), including tracheostomy and total laryngectomy (TL) patients. Significant morbidity and mortality have resulted from first responders’ inability to stabilize the airway until expert airway providers arrive. All medical school graduates should demonstrate competency of this life-saving skill. Our hypothesis was hands-on interactive simulation using 3-dimensional (3D)–printed models would improve AAA knowledge and confidence. Study Design Blinded, prospective cohort study. Setting The Ohio State University College of Medicine. Methods A novel curriculum was designed to teach all third-year medical students AAA fundamentals via case-based discussions, surgical videos, and hands-on student demonstration of competency by inserting a tracheostomy and endotracheal tube through 3D-printed tracheostoma models. Pre- and postcourse 5-item Likert scale surveys and AAA knowledge assessments were administered. Results Students (n = 258) felt more comfortable with knowledge of AAA equipment (3.99 vs 1.38, P < .0001), ability to stabilize AAA patients until expert airway providers arrive (3.67 vs 1.37, P < .0001), and AAA overall (3.75 vs 1.49, P < .0001) postcourse vs precourse. AAA knowledge assessment scores improved from 34.3% precourse to 75.6% postcourse ( P < .0001). Interestingly, 30.7% chose bag-mask ventilation over mouth and nose and/or transoral/transnasal intubation for a total laryngectomy patient precourse vs 5.5% postcourse ( P < .0001). In total, 86.7% reported inadequate exposure to AAA in medical school and 98.4% found the course to be a valuable experience. Conclusion This hands-on course significantly increases medical student knowledge and comfort managing AAA patients. The course can be expanded to various trainees and providers to further promote AAA education and ultimately improve patient safety.

Background Complex facial wounds can be difficult to stabilize due to proximity of vital structures. We present a case in which a patient-specific wound splint was manufactured using computer assisted design and three-dimensional printing at the point-of-care to allow for wound stabilization in the setting of hemifacial necrotizing fasciitis. We also describe the process and implementation of the United States Food and Drug Administration Expanded Access for Medical Devices Emergency Use mechanism. Case presentation A 58-year-old female presented with necrotizing fasciitis of the neck and hemiface. After multiple debridements, she remained critically ill with poor vascularity of tissue in the wound bed and no evidence of healthy granulation tissue and concern for additional breakdown towards the right orbit, mediastinum, and pretracheal soft tissues, precluding tracheostomy placement despite prolonged intubation. A negative pressure wound vacuum was considered for improved healing, but proximity to the eye raised concern for vision loss due to traction injury. As a solution, under the Food and Drug Administration’s Expanded Access for Medical Devices Emergency Use mechanism, we designed a three-dimensional printed, patient-specific silicone wound splint from a CT scan, allowing the wound vacuum to be secured to the splint rather than the eyelid. After 5 days of splint-assisted vacuum therapy, the wound bed stabilized with no residual purulence and developed healthy granulation tissue, without injury to the eye or lower lid. With continued vacuum therapy, the wound contracted to allow for safe tracheostomy placement, ventilator liberation, oral intake, and hemifacial reconstruction with a myofascial pectoralis muscle flap and a paramedian forehead flap 1 month later. She was eventually decannulated and at six-month follow-up has excellent wound healing and periorbital function. Conclusions Patient-specific, three-dimensional printing is an innovative solution that can facilitate safe placement of negative pressure wound therapy adjacent to delicate structures. This report also demonstrates feasibility of point-of-care manufacturing of customized devices for optimizing complex wound management in the head and neck, and describes successful use of the United States Food and Drug Administration’s Expanded Access for Medical Devices Emergency Use mechanism.

Objective: To determine whether a custom laryngectomy tube can improve airway symptoms in total laryngectomy patients with atypical anatomy who are unable to use commercial laryngectomy tubes. Furthermore, to exemplify the power of customizable 3D printed medical devices when combined with the expanded access pathway through the FDA. Methods: A custom-fabricated laryngectomy tube, manufactured at in-house clinical engineering labs, was utilized for each patient following typical laryngectomy tube protocols. All participants had previously undergone a total laryngectomy. Patients were selected based on critical airway obstruction posing potentially life-threatening scenarios while using commercially available laryngectomy tubes. Results: For all patients involved, there were no further airway obstruction complications or events, and they reported a subjective, significant improvement in comfort after placement of the custom laryngectomy tube. Conclusion: Custom laryngectomy tubes can provide patients with atypical anatomy relief from airway obstructions and improve comfort when commercial options fail to address the anatomic restriction. The process used to develop custom laryngectomy tubes may be relevant for other diseases and patients with atypical anatomies through the expanded access pathway.

Background: Complex facial wounds can be difficult to stabilize due to proximity of vital structures. We present a case in which a patient-specific wound splint was manufactured using computer assisted design and three-dimensional printing at the point-of-care to allow for wound stabilization in the setting of hemifacial necrotizing fasciitis. We also describe the process and implementation of the United States Food and Drug Administration Expanded Access for Medical Devices Emergency Use mechanism. Case Presentation: A 58-year-old female presented with necrotizing fasciitis of the neck and hemiface. After multiple debridements, she remained critically ill with poor vascularity of tissue in the wound bed and no evidence of healthy granulation tissue and concern for additional breakdown towards the right orbit, mediastinum, and pretracheal soft tissues, precluding tracheostomy placement despite prolonged intubation. A negative pressure wound vacuum was considered for improved healing, but proximity to the eye raised concern for vision loss due to traction injury. As a solution, under the Food and Drug Administration’s Expanded Access for Medical Devices Emergency Use mechanism, we designed a three-dimensional printed, patient-specific silicone wound splint from a CT scan, allowing the wound vacuum to be secured to the splint rather than the eyelid. After five days of splint-assisted vacuum therapy, the wound bed stabilized with no residual purulence and developed healthy granulation tissue, without injury to the eye or lower lid. With continued vacuum therapy, the wound contracted to allow for safe tracheostomy placement, ventilator liberation, oral intake, and hemifacial reconstruction with a myofascial pectoralis muscle flap and a paramedian forehead flap one month later. She was eventually decannulated and at six-month follow-up has excellent wound healing and periorbital function. Conclusions: Patient-specific, three-dimensional printing is an innovative solution that can facilitate safe placement of negative pressure wound therapy adjacent to delicate structures. This report also demonstrates feasibility of point-of-care manufacturing of customized devices for optimizing complex wound management in the head and neck, and describes successful use of the United States Food and Drug Administration’s Expanded Access for Medical Devices Emergency Use mechanism.